Monday, July 31, 2006

Sanofi, Merck's Gardasil To Launch Europe Oct-Nov

After receiving a positive opinion from E.U. regulators, breakthrough cervical cancer vaccine Gardasil could be available in a number of European countries in late October or early November, Sanofi Pasteur MSD President Didier Hoch said Friday.

Gardasil, which was approved in the U.S. in June, was developed by Sanofi Pasteur MSD, a joint venture between French drugmaker Sanofi-Aventis SA (SNY) and Merck & Co Inc (MRK) of the U.S.

The European launch would follow a final approval for the product from the European Commission, which is expected in early October, Hoch said.

If eventually approved by the European Commission, which usually follows the recommendations of the European regulator's advisory panel, Gardasil would be the first cervical cancer vaccine on the market, ahead of competitor GlaxoSmithKline PLC's (GSK) Cervarix, which is still awaiting approval.

"We plan to first launch in the U.K., Germany and Austria, then Nordic countries, like Denmark and Sweden, and the Netherlands," Hoch said.

The positive opinion came two or three months ahead of expectations, or about seven months after Gardasil's dossier was filed with the E.U. in December 2005, Hoch said.

Earlier Friday, the European Medicines Agency's advisory panel recommended Gardasil for the prevention of cancer, precancerous lesions and genital warts caused by four strains of the human papillomavirus, or HPV, which is the leading cause of cervical cancer.

A three-dose course of Gardasil is expected to cost EUR300, Hoch said.


Extensive Drug Pipeline information at http://www.chartsbank.com/PipelineList.aspx

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